BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 7805492 · Received August 22, 2018

    Report

    Report Number
    2955842-2018-10475
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    July 20, 2018
    Report Date
    July 24, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE. THE DISTAL END OF THE TIP COVER EXHIBITED LOCALIZED MELTING WHICH IS INDICATIVE OF ARCING. A HOLE APPROXIMATELY 0.13¿ X 0.07¿ WAS VISIBLE AT THE BODY OF THE TIP COVER. MATERIAL WAS MISSING. ADDITIONALLY, THE MCS INSTRUMENT ASSOCIATED WITH THIS EVENT WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT AFTER COMPLETION OF DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER NOTED "MELTING" ON THE MCS TIP COVER ACCESSORY. ALTHOUGH, NO PATIENT HARM WAS REPORTED, THE MELTING IS INDICATIVE OF ARCING. RECURRENCE OF THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INSPECTED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY AND FOUND IT WAS "MELTED". THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE AN ATTEMPT TO FOLLOW UP AND OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645655 ENDOWRIST TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14 M11180215

    Patients

    Seq Age Sex Outcome Treatment
    1